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Giving Compass' Take:
• Cara Altimus and Kirstie Keller with LaTese Briggs lay out roles for nonprofits in advancing drug development, expediting a long, costly, and essential process.
• Is getting involved in drug development the right way for you to make an impact?
• Learn how to find and fund scientific research.
Shepherding a drug from discovery to the market is a complex process that involves many actors. The process often begins with academic researchers making a breakthrough discovery in the lab and ends with pharmaceutical companies running large-scale clinical trials to demonstrate that the drug is safe and effective. But what about the middle of this process—the point at which the discovery is translated into something that could be meaningful for treating patients? Who is responsible for the translational, or preclinical, part of the process? There is a lack of clarity about who should assume that role; translational research is often too expensive for academics to perform by themselves, but it is too risky for pharmaceutical companies given the uncertainty about the discovery’s safety and market worthiness.
In this paper, we explore the multitude of methods that nonprofits use to support the translational drug development process in addition to when and where these models are most appropriate. To do so, we discuss several barriers to the translation of scientific discoveries to clinic-ready therapeutics and how nonprofits use their unique approaches to overcome these barriers. This work has led to the creation of a catalogue of activities for nonprofits to support drug development in their specific fields and of the financial mechanisms best suited to fund these activities.
This catalogue includes six main activities: academic support, supporter, incubator, contract research organization (CRO), in-house research and development (R&D), and for-profit development. Each of these activities provides the resources most needed to investigators, companies, or nonprofits themselves to drive drug development efforts forward.
Academic Support: Awards for a principal investigator to conduct discovery and development within their own lab or institution.
Supporter: Offers business and legal education or match-making services for PIs, partners, and funders
Incubator: Offers capital, space, and expertise to its tenants
CRO: Awards to PIs to use CROs to perform critical validation and translation studies
In House R&D: Operated either as the sole focus of the organization or within a nonprofit
For-profit: Support provided to a for-profit to bolster its R&D efforts or begin a new program
The process of developing a new drug is long, costly, and risky. The Pharmaceutical Research and Manufacturers of America (PhRMA) estimates that, on average, it takes 10 years and $2.6 billion to bring a new drug to market.